Trial Outcomes & Findings for Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects (NCT NCT03211234)

Last Updated: 2021-07-13

Results Overview

BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint. An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

Week 24

Results posted on

2021-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Sham Sham and Lucentis Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.	2.0 mg DE-122 Low Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.	4.0 mg DE-122 High Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
Overall Study STARTED	17	31	28
Overall Study COMPLETED	16	30	25
Overall Study NOT COMPLETED	1	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham n=17 Participants Sham and Lucentis Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.	2.0 mg DE-122 n=31 Participants Low Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.	4.0 mg DE-122 n=28 Participants High Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.	Total n=76 Participants Total of all reporting groups
Age, Continuous	75.4 years STANDARD_DEVIATION 9.18 • n=5 Participants	72.1 years STANDARD_DEVIATION 7.34 • n=7 Participants	75.6 years STANDARD_DEVIATION 9.84 • n=5 Participants	74.1 years STANDARD_DEVIATION 8.79 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	41 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	20 Participants n=7 Participants	24 Participants n=5 Participants	52 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	22 participants n=7 Participants	25 participants n=5 Participants	56 participants n=4 Participants
Region of Enrollment Philippines	8 participants n=5 Participants	9 participants n=7 Participants	3 participants n=5 Participants	20 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Sham n=17 Participants Sham and Lucentis Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.	2.0 mg DE-122 n=31 Participants Low Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.	4.0 mg DE-122 n=28 Participants High Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24	4.35 letters Standard Deviation 8.937	0.87 letters Standard Deviation 11.485	-1.70 letters Standard Deviation 10.550

Adverse Events

Sham

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

2.0 mg DE-122

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

4.0 mg DE-122

Serious events: 4 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Sham n=17 participants at risk Sham and Lucentis Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.	2.0 mg DE-122 n=31 participants at risk Low Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.	4.0 mg DE-122 n=28 participants at risk High Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
Eye disorders Cataract	0.00% 0/17 • From Inform consent to the end of the study at week 32.	3.2% 1/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Eye disorders Subretinal fluid	0.00% 0/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	3.6% 1/28 • From Inform consent to the end of the study at week 32.
Cardiac disorders Cardiac arrest	0.00% 0/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	3.6% 1/28 • From Inform consent to the end of the study at week 32.
Infections and infestations Pneumonia	5.9% 1/17 • From Inform consent to the end of the study at week 32.	3.2% 1/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	3.6% 1/28 • From Inform consent to the end of the study at week 32.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	3.6% 1/28 • From Inform consent to the end of the study at week 32.

Other adverse events

Additional Information

R&D Quality Manager

Santen Inc

Phone: +1 415 268 9199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Sham n=17 participants at risk Sham and Lucentis Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.	2.0 mg DE-122 n=31 participants at risk Low Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.	4.0 mg DE-122 n=28 participants at risk High Dose DE-122 and Lucentis DE-122 Injectable Solution + Lucentis: Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
Eye disorders Conjunctival hyperaemia	0.00% 0/17 • From Inform consent to the end of the study at week 32.	6.5% 2/31 • From Inform consent to the end of the study at week 32.	14.3% 4/28 • From Inform consent to the end of the study at week 32.
Eye disorders Eye pain	0.00% 0/17 • From Inform consent to the end of the study at week 32.	12.9% 4/31 • From Inform consent to the end of the study at week 32.	3.6% 1/28 • From Inform consent to the end of the study at week 32.
Eye disorders Conjunctival haemorrhage	11.8% 2/17 • From Inform consent to the end of the study at week 32.	9.7% 3/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Eye disorders Conjunctival oedema	0.00% 0/17 • From Inform consent to the end of the study at week 32.	3.2% 1/31 • From Inform consent to the end of the study at week 32.	7.1% 2/28 • From Inform consent to the end of the study at week 32.
Eye disorders Erythema of eyelid	0.00% 0/17 • From Inform consent to the end of the study at week 32.	3.2% 1/31 • From Inform consent to the end of the study at week 32.	7.1% 2/28 • From Inform consent to the end of the study at week 32.
Eye disorders Retinal haemorrhage	0.00% 0/17 • From Inform consent to the end of the study at week 32.	9.7% 3/31 • From Inform consent to the end of the study at week 32.	10.7% 3/28 • From Inform consent to the end of the study at week 32.
Eye disorders Eyelid oedema	0.00% 0/17 • From Inform consent to the end of the study at week 32.	3.2% 1/31 • From Inform consent to the end of the study at week 32.	10.7% 3/28 • From Inform consent to the end of the study at week 32.
Eye disorders Visual impairment	0.00% 0/17 • From Inform consent to the end of the study at week 32.	3.2% 1/31 • From Inform consent to the end of the study at week 32.	7.1% 2/28 • From Inform consent to the end of the study at week 32.
Investigations Intraocular pressure increased	0.00% 0/17 • From Inform consent to the end of the study at week 32.	6.5% 2/31 • From Inform consent to the end of the study at week 32.	3.6% 1/28 • From Inform consent to the end of the study at week 32.
Eye disorders Dry Eye	0.00% 0/17 • From Inform consent to the end of the study at week 32.	6.5% 2/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Eye disorders Vitreous hemorrhage	0.00% 0/17 • From Inform consent to the end of the study at week 32.	6.5% 2/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Investigations Alanine aminotransferase increased	5.9% 1/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Investigations Aspartate aminotransferase increased	5.9% 1/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Nervous system disorders Headache	0.00% 0/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	7.1% 2/28 • From Inform consent to the end of the study at week 32.
Nervous system disorders Presyncope	5.9% 1/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Infections and infestations Viral upper respiratory tract infection	5.9% 1/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	3.6% 1/28 • From Inform consent to the end of the study at week 32.
General disorders Pyrexia	5.9% 1/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • From Inform consent to the end of the study at week 32.	0.00% 0/31 • From Inform consent to the end of the study at week 32.	0.00% 0/28 • From Inform consent to the end of the study at week 32.